Study to Assess the Immune Reactivity of the Liquid and Lyophilized Formulations of Palivizumab (MEDI-493, Synagis)

Overview

The purpose of this study is to measure the rate of anti-palivizumab antibodies (also referred to as immune reactivity or immunogenicity) in subjects receiving either the liquid or lyophilized formulation of palivizumab. This study will compare the number and percentage of subjects with anti-palivizumab antibodies receiving either the liquid or lyophilized formulation of palivizumab.

Full Title of Study: “A Phase IV, Randomized, Double-Blind Study to Assess the Immune Reactivity of the Liquid and Lyophilized Formulations of Palivizumab (MEDI-493, Synagis) in Children at High Risk for the Development of Serious RSV Disease”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: October 2007

Detailed Description

The approved liquid formulation of palivizumab was developed to simplify preparation of the drug before injection. Both formulations of palivizumab have been shown to be bioequivalent in children 6 months of age or younger with a history of chronic lung disease. In previous studies of liquid palivizumab, immunogenicity was evaluated up to 2 months after dosing in adults, and 1 month after dosing in children. In this study, MI-CP116, immunogenicity will be evaluated between 4 and 6 months after the last dose of study drug, in order to provide data at a time point significantly distant from dosing when drug interference is minimal.

Interventions

  • Biological: Lyophilized Palivizumab
    • Patients will receive 15 mg/kg of lyophilized palivizumab administered intramuscularly every 30 days for a total of 5 injections.
  • Biological: Liquid Palivizumab
    • Patients will receive 15 mg/kg of liquid palivizumab administered intramuscularly every 30 days for a total of 5 injections.

Arms, Groups and Cohorts

  • Active Comparator: 1
    • Liquid Palivizumab
  • Active Comparator: 2
    • Lyophilized Palivizumab

Clinical Trial Outcome Measures

Primary Measures

  • Number and Percentage of Participants With Immune Reactivity
    • Time Frame: Day 240-300 follow up
    • Presence of anti-palivizumab antibodies

Participating in This Clinical Trial

Inclusion Criteria

  • Medically stable child with chronic lung disease of prematurity who is ≤24 months of age at randomization OR child with premature birth (gestational age ≤35 weeks or less) and who is 6 months of age or younger at randomization – Written informed consent obtained from the patient's parent(s) or legal guardian(s) – The child must be able to complete the follow-up visit 4-6 months after the last dose of study drug Exclusion Criteria:

  • Hospitalization at the time of randomization (unless discharge is anticipated within 3 weeks) – Be receiving mechanical ventilation at the time of study entry (including CPAP) – Congenital heart disease (children with uncomplicated CHD [e.g., PDA, small septal defect] and children with complicated CHD who are currently anatomically and hemodynamically normal can be enrolled). – Mother with HIV infection (unless the child has been proven to be not infected) – Life expectancy <6 months – Known allergy to Ig products – Acute respiratory or other acute infection or illness – Previous reaction to IGIV, blood products, or other foreign proteins – Receipt of lyophilized palivizumab, RSV-IG IV, or other RSV-specific monoclonal antibody, or any other polyclonal antibody (for example, Hepatitis B IG, IVIG, VZIG) within 3 months prior to randomization – Any previous receipt of MEDI-524 – Participation in other investigational drug product studies

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: 24 Months

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • MedImmune LLC
  • Provider of Information About this Clinical Study
    • Genevieve Losonsky, M.D., MedImmune Inc.
  • Overall Official(s)
    • Genny Losonsky, MD, Study Director, MedImmune LLC

References

Makari D, Jensen KM, Harris B, Jafri HS. Randomized, Double-Blind Study of the Safety of the Liquid Versus Lyophilized Formulation of Palivizumab in Premature Infants and Children with Chronic Lung Disease of Prematurity. Infect Dis Ther. 2014 Dec;3(2):339-47. doi: 10.1007/s40121-014-0033-y. Epub 2014 Aug 26.

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